Non-Small Cell Lung Cancer
Conditions
Keywords
SKB264, NSCLC
Brief summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Detailed description
This is a randomized, open-Label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with osimertinib versus osimertinib alone as first-line treatment for patients with EGFR mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Interventions
DRUGSKB264
4mg/kg, intravenous (IV) infusion
DRUGOsimertinib
80mg, QD
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender. 2. Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not eligible to radical surgery and/or radical radiotherapy. 3. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. 4. Histologically or cytologically confirmed EGFR-sensitive mutations. 5. Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible. 6. At least one target lesion assessed by the investigator based on RECIST v1.1. 7. ECOG performance status score of 0 or 1 within 7 days prior to randomization. 8. Life expectancy ≥ 12 weeks. 9. Adequate organ and bone marrow function.
Exclusion criteria
1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%. 2. Subjects who have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. 3. Subjects who have received any of the following therapies (including the adjuvant/neoadjuvant therapy): 1. Targeted TROP2 therapy; 2. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs). 4. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or central nervous system (CNS) metastase. 5. Other malignancies within 3 years prior to randomization. 6. Clinically significant abnormalities found on resting electrocardiogram (ECG) 7. Presence of any of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors. 8. History of interstitial lung disease (ILD), drug-induced ILD, history of non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis. 9. Clinically severe lung injuries caused by lung diseases. 10. Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0) or the level specified in the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) | Randomization up to approximately 36 months | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Randomization up to approximately 49 months | OS is defined as the time from randomization until the date of death due to any cause. |
| Progression-Free Survival (PFS) assessed by Investigator | Randomization up to approximately 36 months | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first. |
| Objective Response Rate (ORR) | Randomization up to approximately 36 months | ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1 |
| Disease control rate (DCR) | Randomization up to approximately 36 months | DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1 |
| Duration of Response (DoR) | Randomization up to approximately 36 months | DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first. |
| Time to Response (TTR) | Randomization up to approximately 36 months | TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1. |
Countries
China
Outcome results
None listed